Use of Electronic Personal Health Records to Improve Medication Adherence
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||The Use of Electronic Personal Health Records to Improve Medication Adherence Among Non-Valvular Atrial Fibrillation Patients: A Pilot Study|
- Medication Adherence evaluated through medication possession ratios [ Time Frame: 3 months during study ] [ Designated as safety issue: No ]
- Patient Engagement evaluated through Patient Activation Measure (PAM) [ Time Frame: 3 months during study ] [ Designated as safety issue: No ]
- Medication Knowledge evaluated through 5-question survey [ Time Frame: 3 months during study ] [ Designated as safety issue: No ]
|Study Start Date:||February 2014|
|Study Completion Date:||July 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Medication Education
Patients will receive training on the use of the personal health record and health education via the personal health record.
Other: Medication Education
Medication education delivered via the personal health record (MyChart) pertinent to the anticoagulation medication dabigatran. Education newsletters will be sent at 4, 6, and 10 weeks post-enrollment.
No Intervention: No Medication Education
Patients will receive the current standard of care for the personal health record. Patients will not receive training on the use of the personal health record or health education via the personal health record.
Three brief newsletters will be sent by the research staff to the study patients in the form of secure messages through their MyChart account. The newsletters will describe dabigatran tolerability, adverse effects, patient monitoring, warnings/precautions, and administration. Newsletters will be developed through a review of the FDA-approved prescribing information, general tertiary references, and a search of PubMed and drafted with guidance from a Drug Information Specialist at Manchester University College of Pharmacy as well as reviewed by the research staff.
Descriptive analysis will be used to analyze the survey to assess patient attitudes and beliefs about dabigatran and personal health records, as well as to assess the level of patient engagement. Difference-in-difference regression analysis will be used to evaluate the impact of the personal health record on dabigatran adherence by comparing the differences between times (pre-post) and interventions. Patient medication adherence will be correlated from the Pharmacy refill data to determine if the Intervention Group is more compliant than the Control Group. Multivariate analysis will be used to explore factors influencing personal health record use and dabigatran adherence.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03018197
|United States, Indiana|
|Parkview Research Center; Parkview Health|
|Fort Wayne, Indiana, United States, 46845|
|Principal Investigator:||Michael Mirro, MD||Parkview Health|
|Principal Investigator:||Ozlem Ersin, PhD||Manchester University College of Medicine|